BEUDAMED
    FDA Recall Terminated

    ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021

    Recall: Z-0510-2021 · Initiated November 5, 2020

    Recall

    Recall Number
    Z-0510-2021
    Event Number
    86798
    Firm
    VEO DIAGNOSTICS, LLC
    FEI Number
    3017223053
    Product Code
    QMN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 5, 2020
    Terminated
    April 16, 2021
    Address
    422 Wards Corner Rd, Loveland, OH, 45140-6964

    Description

    ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021

    Reason

    Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests

    Action

    Plexense issued NOTICE IMPORTANT PRODUCT WITHDRAWAL dated 11/5/20, stating reason for withdrawal, health risk and action take: clinical decisions. " If this test has been used to make clinical decisions, evaluate each patients clinical presentation and medical history, whether prior test results generated using this test may have been incorrect, and whether the patient should be retested using an FDA-authorized test. " Complete the Customer Response Form that accompanies this letter and return it to VEO Diagnostics, Plexenses US distributor, to confirm that you have received and understand this Notification. VEOs return address is listed on the Customer Response Form. " Remove from your stock any remaining ACCEL ELISA COVID-19 tests that you have in your possession and discard those kits. Indicate their destruction or disposal on the Customer Notification Form. You DO NOT need to return the kits to VEO Diagnostics or Plexense, Inc. " If you were using ACCEL ELISA COVID-19 for research purposes, and you wish to continue with your research, please contact VEO Diagnostics at 513-965-3140 for assistance with obtaining replacement materials to continue your research. Should you have additional questions regarding this Notification, or if you need assistance, please contact VEO Diagnostics Product Support team at: Telephone : 513-965-3140 Fax : 513-961-2858

    Distribution

    US Nationwide distribution including in the states of IA, PA, WA.

    Quantity

    15 kits